CUDC-907 for Lymphoma

Phase-Based Estimates
1
Effectiveness
1
Safety
Texas Children's, Baylor College of Medicine, Houston, TX
Lymphoma+5 More
CUDC-907 - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Lymphoma

Study Summary

This study is evaluating whether a drug may help treat children with cancer.

See full description

Eligible Conditions

  • Lymphoma
  • Brain Cancer
  • Neuroblastoma
  • Cancer
  • Brain Neoplasms
  • Tumors, Solid
  • Neoplasms, Brain
  • Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether CUDC-907 will improve 1 primary outcome and 6 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of 2 months.

2 months
Objective Response
2 years
Adverse Events per CTCAE Version 4
Dose Limiting Toxicity
Duration of Response
Exposure (AUC) of CUDC-907 in Pediatrics
Peak plasma concentration of CUDC-907 in Pediatrics
Progression Free Survival

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Side Effects for

CUDC-907
Diarrhea
72%
Hypokalemia
54%
Nausea
49%
Thrombocytopenia
41%
Hypomagnesia
40%
Fatigue
35%
Decreased appetite
34%
Dehydration
28%
Vomiting
28%
Anemia
26%
Dyspnea
26%
Constipation
21%
Neutropenia
21%
Arthralgia
21%
Dizziness
19%
Pyrexia
19%
Hyperuricemia
19%
Pain in extremity
19%
Hypocalcemia
18%
Abdominal Pain
18%
Back pain
16%
Acute Kidney Injury
16%
Cough
13%
Peripheral edema
12%
Diffuse Large B Cell lymphoma
10%
Upper Respiratory Infection
9%
Musculoskeletal pain
9%
Oropharyngeal Pain
9%
Headache
9%
Atrial fibrillation
7%
Pruritus
7%
Asthensia
7%
Dysgeusia
7%
Insomnia
6%
Dyspepsia
6%
Chills
6%
Sepsis
6%
Diarhhea
4%
Lymphoma
4%
Non-cardiac chest pain
1%
hyperbilirubenemia
1%
Tracheal obstruction
1%
Small Intestinal Obstruction
1%
Pulmonary Embolism
1%
Cytomegalovirus
1%
Abdominal Pain Upper
1%
Gullain-Barre Syndrome
1%
Disease Progression
1%
Citrobacter Batremia
1%
Wound infection
1%
Cholecystitis
1%
Device occulsion
1%
Asthenia
1%
Enterococcal
1%
Pneumonia
1%
Febrile Neutropenia
1%
COPD
1%
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT02674750) in the CUDC-907 ARM group. Side effects include: Diarrhea with 72%, Hypokalemia with 54%, Nausea with 49%, Thrombocytopenia with 41%, Hypomagnesia with 40%.

Trial Design

2 Treatment Groups

Control
CUDC-907

This trial requires 44 total participants across 2 different treatment groups

This trial involves 2 different treatments. CUDC-907 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

CUDC-907
Drug
CUDC-907 orally administered CUDC-907 once daily for 5 consecutive days per week followed by two days without dosing Dose level assigned at registration Pre-dose pharmacokinetic blood sample will be collected Dose escalation will follow a standard 3+3 design
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CUDC-907
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Who is running the study

Principal Investigator
D. S. S.
David S Shulman, MD
Dana-Farber Cancer Institute

Closest Location

Texas Children's, Baylor College of Medicine - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Lymphoma or one of the other 5 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
For Part A, participants must have histologically confirmed solid tumors, CNS tumors, or lymphoma based upon biopsy or surgery at initial diagnosis and/or relapse/progression. The only exception to histologic confirmation is for pediatric tumors that are routinely diagnosed exclusively by standard clinical imaging criteria: diffuse intrinsic pontine glioma and optic pathway glioma.
MYCN amplification (> 4 copy amplification) from COG reference laboratory or other CLIA-certified laboratory; or Mycn protein expression > 1+ according to validated assay in Children's Hospital Los Angeles (CHLA) Clinical Pathology Laboratory; or Myc expression > 1+ according to validated assay in CHLA Clinical Pathology Laboratory.
Diagnosis requirement
Age > 1 years and ≤ 21 years at time of enrollment.
Karnofsky performance status ≥ 50% for patients ≥16 years of age and Lansky ≥ 50% for patients <16 years of age (see Appendix A)
For Parts A and B, participants must have evaluable or measurable disease (see Section 11).
Burkitt lymphoma
Participants must have disease that is relapsed or refractory and for which standard curative or palliative measures do not exist or are no longer effective.
Myelosuppressive chemotherapy: At least 14 days after the last dose of myelosuppressive chemotherapy (42 days for nitrosourea or mitomycin C).
Diffuse large B cell lymphoma

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for lymphoma?

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In lymphoma, treatment varies depending on the type of cancer, how dangerous it is, whether the cancer is in lymph nodes near the skin, and the extent of the disease. Most cases of lymphoma were treated with radiation therapy with some combination of other techniques. Most cases of lymphoma are treatable, but only half of lymphoma cases can be cured.

Unverified Answer

How many people get lymphoma a year in the United States?

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In order to implement more effective and sustained surveillance programs for this population, accurate numbers on the size and impact of lymphomas are needed in the United States. According to the estimates obtained in this investigation, around 10,000 to 18,000 new cases can be diagnosed yearly in the United States. However, the number of lymphoma deaths exceeds that by a four-to-one margin (about 43,000 to 97,000), with only 730 to 1,200 physicians practicing in the country. This suggests the need for more awareness and better medical education of physicians and other medical personnel about lymphoma.

Unverified Answer

Can lymphoma be cured?

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Immunosuppression reduces the risk of disease recurrence, but does not result in prolonged survival time. However, the long-term survival rates are very good. Surgical removal of the primary cancer is a prerequisite for long-term survival.

Unverified Answer

What is lymphoma?

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Lymphoma is a cancer that forms mainly in the lymphatic system and spreads to other parts of the body. While about 20 million people will be affected by the disease, only a few millions of people actually develop a tumor. Primary lymphomas are more common in early adulthood, women, and Caucasians. Histologically, the most common form is non-Hodgkin's lymphoma, and it has an excellent prognosis. The cancer is diagnosed by a lymph node biopsy as a disease that is treated by chemotherapy and radiotherapy.

Unverified Answer

What are the signs of lymphoma?

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The most common signs of lymphoma are enlarged lymph nodes (75%), fever (43%), weight loss (44%), cough (39%), night sweats (36%), skin changes (33%), chest pain (33%), headache (33%), and loss of lean mass (21%). For lymphoproliferative disorders, swollen lymph nodes (89%), skin rash (48%), swollen lymph nodes (43%), night sweats (40%), fever (38%), and weight loss (29%) are the most common signs, whereas lymphoma with B immunophenotype presents with anemia, anorexia, and fever (38%), enlarged lymph nodes (38%), and night sweats (38%).

Unverified Answer

What causes lymphoma?

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  1. Tobacco Smoking - smokers are at higher risk of NHL.\n2. Alcohol - heavy drinking poses an elevated risk.\n3. Immunodeficiency - most are exposed to human immunodeficiency virus (HIV).\n4. Childhood diseases. Recent studies have linked chronic Epstein-Barr virus (EBV), HHV-6, HHV-7 to risk of NHL.\n5. Other Childhood Infections - Recent studies have linked other childhood infections. These include hepatitis B, cytomegalovirus, herpes simplex, varicella virus in association with NHL.
Unverified Answer

What is the survival rate for lymphoma?

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Lymphoma has a very poor outlook. The overall five year survival rate can be as low as 16% in the case of marginal zone B-cell lymphoma and even less in other types of lymphoma like mantle cell lymphoma, which is an extremely refractory cancer.

Unverified Answer

What does cudc-907 usually treat?

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Findings from a recent study, cudc-907 treatment led to clinical improvements and long term tumor control in both treatment naïve and pretreated patients with newly diagnosed and/or relapsing disease. In fact, the combination of cudc-907 with rituximab resulted in higher rates of CR compared to either agent alone and resulted in longer PFS. Future studies in combination and single agents are ongoing to better characterize the role of cudc-907 in treating DLBCL.

Unverified Answer

What is the average age someone gets lymphoma?

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A majority of individuals with lymphoma report that their diagnosis was not the result of one problem with their health but rather multiple unhealthy behaviors. The most common causes for development of lymphoma were the behaviors of smoking or marijuana use and obesity. There is a need to address the multiple unhealthy behaviors of smoking, marijuana use, and obesity in order to prevent the development of a lymphoma and to facilitate the treatment of individuals with lymphoma.

Unverified Answer

What are the latest developments in cudc-907 for therapeutic use?

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Cudc-907 could be the next successful anticancer drug for treating certain types of acute myeloid leukaemia. As a protein tyrosine kinase (PTK), Cudc-907 directly inhibits T-cell leukaemia protein (TCL-1) and BCR/ABL kinase (BCR) enzymes and in the same time reverses several abnormal kinase activities of TCL-1 and BCR. Therefore, Cudc-907 has a unique and selective anti-kinase and selective antiproliferative profile. This leads to improved TCL-1 and BCR protein levels and decreased the proliferation of T-cell leukaemia.

Unverified Answer

What is the latest research for lymphoma?

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Lymphoma was a significant disease in all four countries, with the USA, Canada and the UK having the most. Although the overall incidence is decreasing, lymphoma remains one of the most significant diseases treated in Western countries.

Unverified Answer

Has cudc-907 proven to be more effective than a placebo?

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The addition of Cudc-907 to standard chemotherapy had no effect on progression-free or overall survival. Patients who had cudc-907 had a trend toward higher overall response rates than did patients who received the placebo. The drug was well tolerated.

Unverified Answer
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